LAB CSV IT Benchtop Support
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We are seeking an experienced IT Systems & Computerized System Validation (CSV) Specialist to oversee and support validated systems within pharmaceutical manufacturing operations. The role involves managing sitewide IT upgrades, ensuring compliance with GxP regulations, supporting cross-functional teams, and maintaining data integrity and cybersecurity standards.
Key Responsibilities
Project & Stakeholder Management
- Oversee sitewide Windows 11 desktop PC upgrade projects, engaging with stakeholders and vendors, managing timelines, resources, and risks.
- Coordinate with vendors to assess software compatibility with Windows 11 OS.
- Communicate risks, limitations, and project updates to stakeholders for successful execution.
Systems Administration & Support
- Provide day-to-day support for manufacturing shopfloor systems, ensuring minimal downtime.
- Perform user access management, recertification, audit trail reviews, backups, restores, and data archival.
- Apply change control procedures, assess impact, and prepare stakeholder communications.
- Validation & Documentation
- Draft and review design and qualification documentation using Kneat platform.
- Generate and execute validation protocols (IQ, OQ, PQ) for GxP computerized systems.
- Perform qualification and decommissioning of shopfloor devices and laboratory systems.
- Data Integrity & Cybersecurity
- Manage data migration, backup, and archiving processes, ensuring compliance and security.
- Configure and maintain networking systems (firewalls, DNS, IP management, cable patching).
- Collaborate with cybersecurity teams to identify and mitigate threats, ensuring data integrity.
- Contribute to major initiatives such as implementation of new backup solutions and system decommissioning.
- Qualifications & Requirements
- Bachelor's degree in Computer Science, Information Technology, Engineering, or related field.
- 5–8 years of experience in IT systems support, CSV, and pharma manufacturing environments.
- Strong knowledge of GxP/GMP compliance, validation processes, and regulatory requirements.
- Hands-on expertise in IT systems administration, networking, and cybersecurity.
- Experience with Kneat platform and validated system documentation.
- Excellent communication, stakeholder management, and cross-functional collaboration skills.